Combinostics Oy
FI-MF-000011968 · Finland · Tampere
Combinostics Oy is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 8 |
|---|
Among these devices, 8 are declared active.
Devices declared under this manufacturer
- cNeuro cDAT
Catalogue references include 2, cNeuro cDAT, cNeuro cDSI, cNeuro cMRI, cNeuro cPET.
European nomenclature codes declared: V92.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | COMBINOSTICS (FI) · FDA 3014470527 |
| Devices in EUDAMED | 8 |
| Country of registration | Finland |
Device-level evidence
| Devices with a numeric GTIN | 8 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 37.5 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Combinostics Oy is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FI22/871878 | supplemented | 2025-05-07 |
FI22/871878 | supplemented | 2030-02-19 |